title: Design and analysis of post-marketing research.
abstract: A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.
authors.affiliation: Department of Biostatistics, School of Public Health, University of Washington, Washington, USA.
authors.forename: Xiao-Hua Andrew
authors.initials: XH
authors.lastname: Zhou
authors.forename: Wei
authors.initials: W
authors.lastname: Yang
mesh_terms: D000707:Anaphylaxis / Q000139:chemically induced; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects; D016571:Neural Networks, Computer; D011358:Product Surveillance, Postmarketing; D012107:Research Design; D012206:Rhabdomyolysis / Q000139:chemically induced
chemical_list: D004365:Drugs, Chinese Herbal; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors